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U.S. Department of Health and Human Services

Import Refusal Report

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Refusal Actions by FDA as Recorded in OASIS

for 61-Human and Animal Drugs


Entry/doc/line/sfx Refusal Date Product
Code
Manufacturer
FEI
Manufacturer
Name
Manufacturer
Country/Area
M21-0742532-6/2/1 10-Nov-2010 61EAA08 3005144955 Chemo S.A. Lugano Branch Switzerland
 
112-8872518-0/2/1 08-Nov-2010 61ECA08 3007801566 Hexal Polsak Poland
 
XXX-0261165-6/1/3 09-Nov-2010 61ECA08 3005116440 Laboratorios Leti Venezuela
 
AEK-8356909-1/2/1 02-Nov-2010 61ECB09 3008525266 Dr J L Babsal India
 
KM6-0048439-8/6/1 04-Nov-2010 61FBN21 3003452796 Reckitt Benckiser India
 
144-3536670-6/1/1 12-Nov-2010 61GDS48 3004365047 Suzhou Wugan Chemical Co., Ltd. China
 
112-9128177-6/2/2 30-Nov-2010 61JAA14 3006659689 Therapharma Inc Philippines
 
112-8839451-6/1/3 08-Nov-2010 61JCB08 3007047830 Opsonin Pharmaceutical Ltd Bangladesh
 
XXX-0261165-6/1/2 09-Nov-2010 61LCA13 3002882042 BRISTOL-MYERS SQUIBB HLDG United States
 
112-8839451-6/1/1 08-Nov-2010 61LDB38 3003670128 Square pharmaceuticals Ltd Bangladesh
 
112-9667034-6/1/1 19-Nov-2010 61MCA40 3003684198 Janssen Ortho United States
 
112-8332812-1/1/1 15-Nov-2010 61MCA99 3005753354 Sanofi Aventis United Kingdom
 
112-8838626-4/1/1 05-Nov-2010 61NCB05 3007795063 Glaxosmithkline Czech Republic
 
DO7-8234552-7/1/5 01-Nov-2010 61NDA03 3008567310 Park Jin Yong Korea, Republic Of (South)
 
DO7-8234552-7/1/7 01-Nov-2010 61NDA69 3008567310 Park Jin Yong Korea, Republic Of (South)
 
112-8937823-7/1/1 15-Nov-2010 61PCA31 3007258228 Instituto Farmaceutico Labomed Chile
 
DO7-8234552-7/1/3 01-Nov-2010 61PDA09 3008567310 Park Jin Yong Korea, Republic Of (South)
 
DO7-8234552-7/1/4 01-Nov-2010 61PDA99 3008567310 Park Jin Yong Korea, Republic Of (South)
 
AEK-8356728-5/2/1 02-Nov-2010 61PDB17 3008521477 Tamanna Islam United Arab Emirates
 
AEK-8348296-4/1/1 02-Nov-2010 61PDK17 3008533401 Stuart Finlay United Kingdom
 
AEK-8356728-5/1/1 02-Nov-2010 61PDL17 3008521477 Tamanna Islam United Arab Emirates
 
AEK-8357549-4/1/1 10-Nov-2010 61SCJ99 3008537268 Shruti Kothari India
 
AEK-8357549-4/1/2 10-Nov-2010 61SCJ99 3008537268 Shruti Kothari India
 
DO7-8234552-7/1/8 01-Nov-2010 61TDA06 3008567310 Park Jin Yong Korea, Republic Of (South)
 
112-8888708-9/2/1 15-Nov-2010 61WAA45 3004122668 Mavi Sa de CV Mexico
 
112-9059137-3/2/1 30-Nov-2010 61WCY55 3008542921 Johnson & Johnson Philippines
 
AEK-8356909-1/1/1 02-Nov-2010 61XCB99 3008525266 Dr J L Babsal India
 
112-7524985-6/5/1 04-Nov-2010 61XCS36 2129414 Fontarome Chemical, Inc. United States
 
112-8823583-4/1/1 09-Nov-2010 61XDL14 3003809639 MEYER ORGANICS LTD India
 
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